Characterizing SARS-CoV-2-specific Immunity in Individuals Who Have Recovered From COVID-19
NCT ID: NCT04403880
Last Updated: 2026-01-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
760 participants
OBSERVATIONAL
2020-05-13
2022-04-21
Brief Summary
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The information gained from the study will be used to help develop better tests for SARS-CoV-2 infection and COVID-19 disease and may help in developing future vaccines and treatments by allowing researchers to determine the difference between the body's immune response to natural SARS-CoV-2 infection and immunization with a SARS-CoV-2 vaccine.
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Detailed Description
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The observational cohort study will include 3 groups, as described in the table below.
Participants will complete a minimum of one visit (1-8 weeks post resolution of COVID-19 OR 2-10 weeks post most recent positive SARS-CoV-2 test, if asymptomatic) and optional visits approximately 2 months, 4 months, and 1 year later. Participants diagnosed with SARS-CoV-2 infection at an optional follow-up visit may be contacted more frequently. Additional follow up visit(s) may be added over time in response to evolving information regarding SARS-CoV-2 infection and COVID-19.
Study visits may include physical examinations, medical history, questionnaires, pregnancy tests (for participants assigned female at birth), blood draws, optional nasal samples, and optional HIV testing.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Group 1
Persons not hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3
* 1A: Persons with asymptomatic infection, ages 18 through 55, inclusive
* 1B: Persons with asymptomatic infection, age \> 55
* 1C: Persons with symptomatic infection (ie, COVID-19) ages 18 through 55
* 1D: Persons with symptomatic infection (ie, COVID-19), age \> 55
Sample collection
* Optional nasal specimen(s)
* Blood collection
Group 2
Persons previously hospitalized for COVID-19, without clinical spectrum or outcomes specified in group 3
* 2A: Persons 18 through 55 years of age
* 2B: Persons \> 55 years of age
Sample collection
* Optional nasal specimen(s)
* Blood collection
Group 3
Persons with specific clinical spectrums or outcomes, regardless of hospitalization history (eg, persons recovered after intubation, with prolonged viral shedding, with myocarditis/pericarditis, with rapid recovery from COVID-19, with a second positive SARS-CoV-2 RT-PCR test result after a negative result)
Sample collection
* Optional nasal specimen(s)
* Blood collection
Interventions
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Sample collection
* Optional nasal specimen(s)
* Blood collection
Eligibility Criteria
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Inclusion Criteria
* Reports having had a positive test for SARS-CoV-2.
* Reports resolution of COVID-19 within 1-8 weeks of enrollment OR, if asymptomatic infection, reports positive SARS-CoV-2 test within 2-10 weeks of enrollment. Not excluded: individuals with symptoms consistent with residual sequelae of resolved COVID-19, in the clinical judgement of the investigator.
* Access to a participating HVTN or HPTN CRS and willingness to be followed for the planned duration of the study.
* Ability and willingness to provide informed consent.
* Assessment of understanding: volunteer demonstrates understanding of this study.
* Volunteers who were assigned female sex at birth: negative urine or serum beta human chorionic gonadotropin (β-HCG) pregnancy test within 4 days of enrollment visit (ie, prior to enrollment blood draw or nasal collections). Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records) or having reached menopause (no menses for ≥ 1 year ), are not required to undergo pregnancy testing.
Exclusion Criteria
* Pregnant.
* Receipt of SARS-CoV-2 specific antibodies (eg, convalescent plasma or sera, monoclonal antibodies, hyperimmune globulin). Not excluded: antibody therapy without SARS-CoV-2 specificity (eg, IL-6 pathway inhibitors for COVID-19).
* SARS-CoV-2 vaccine(s) received in a prior vaccine trial.
* Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a volunteer's ability to give informed consent.
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
HIV Prevention Trials Network
NETWORK
HIV Vaccine Trials Network
NETWORK
Responsible Party
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Principal Investigators
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Larry Corey
Role: STUDY_CHAIR
HIV Vaccine Trials Network, Fred Hutch
Shelly Karuna
Role: STUDY_CHAIR
HIV Vaccine Trials Network, Fred Hutch
Locations
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Alabama Vaccine CRS
Birmingham, Alabama, United States
UCLA CARE Center CRS
Los Angeles, California, United States
Bridge HIV CRS
San Francisco, California, United States
George Washington University CRS
Washington D.C., District of Columbia, United States
The Ponce de Leon Center CRS
Atlanta, Georgia, United States
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, United States
Adolescent & Young Adult Research at The CORE Center (AYAR at CORE)
Chicago, Illinois, United States
New Orleans Adolescent Trials Unit CRS
New Orleans, Louisiana, United States
Johns Hopkins University CRS
Baltimore, Maryland, United States
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, United States
Fenway Health Clinical Research Site CRS
Boston, Massachusetts, United States
New Jersey Medical School Clinical Research Center CRS
Newark, New Jersey, United States
Harlem Prevention Center CRS
New York, New York, United States
Columbia P&S CRS
New York, New York, United States
New York Blood Center CRS
New York, New York, United States
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, United States
Bronx Prevention Research Center CRS
The Bronx, New York, United States
Chapel Hill CRS
Chapel Hill, North Carolina, United States
Penn Prevention CRS
Philadelphia, Pennsylvania, United States
Vanderbilt Vaccine CRS
Nashville, Tennessee, United States
Seattle Vaccine and Prevention CRS
Seattle, Washington, United States
Malawi CRS
Lilongwe, , Malawi
San Miguel CRS
San Miguel, Lima region, Peru
Asociacion Civil Selva Amazonica (ACSA) CRS
Iquitos, Maynas, Peru
CITBM - UNIDEC, Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS
Bellavista, Provincia Constitucional del Callao, Peru
Via Libra CRS
Lima, , Peru
Barranco CRS
Lima, , Peru
Josha Research CRS
Bloemfontein, , South Africa
Emavundleni CRS
Cape Town, , South Africa
Groote Schuur HIV CRS
Cape Town, , South Africa
Khayelitsha CRS / (CIDRI UCT)
Cape Town, , South Africa
Masiphumelele Clinical Research Site (MASI) CRS
Cape Town, , South Africa
Chatsworth CRS
Chatsworth, , South Africa
Botha's Hill CRS
Durban, , South Africa
CAPRISA eThekwini CRS
Durban, , South Africa
Vulindlela CRS
Durban, , South Africa
Isipingo CRS
Isipingo, , South Africa
Kliptown Soweto CRS
Johannesburg, , South Africa
Soweto HVTN CRS
Johannesburg, , South Africa
Aurum Institute Klerksdorp CRS
Klerksdorp, , South Africa
Qhakaza Mbokodo Research Clinic CRS
Ladysmith, , South Africa
Nelson Mandela Academic Research Unit CRS
Mthatha, , South Africa
Synexus Stanza Clinical Research Centre CRS
Pretoria, , South Africa
Rustenburg CRS
Rustenburg, , South Africa
Setshaba Research Centre CRS
Soshanguve, , South Africa
Tembisa Clinic 4 CRS
Tembisa, , South Africa
The Aurum Institute Tembisa Clinical Research Centre CRS
Tembisa, , South Africa
Tongaat CRS
Tongaat, , South Africa
Verulam CRS
Verulam, , South Africa
Matero Reference Clinic CRS
Lusaka, , Zambia
St Mary's CRS
Chitungwiza, , Zimbabwe
Zengeza CRS
Chitungwiza, , Zimbabwe
Seke South CRS
Harare, , Zimbabwe
Countries
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References
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Karuna S, Gallardo-Cartagena JA, Theodore D, Hunidzarira P, Montenegro-Idrogo J, Hu J, Jones M, Kim V, De La Grecca R, Trahey M, Karg C, Takalani A, Polakowski L, Hutter J, Miner MD, Erdmann N, Goepfert P, Maboa R, Corey L, Gill K, Li SS; HVTN 405/HPTN 1901 Study Team. Post-COVID symptom profiles and duration in a global convalescent COVID-19 observational cohort: Correlations with demographics, medical history, acute COVID-19 severity and global region. J Glob Health. 2023 Jun 23;13:06020. doi: 10.7189/jogh.13.06020.
Karuna S, Li SS, Grant S, Walsh SR, Frank I, Casapia M, Trahey M, Hyrien O, Fisher L, Miner MD, Randhawa AK, Polakowski L, Kublin JG, Corey L, Montefiori D; HVTN 405/HPTN 1901 Study Team. Neutralizing antibody responses over time in demographically and clinically diverse individuals recovered from SARS-CoV-2 infection in the United States and Peru: A cohort study. PLoS Med. 2021 Dec 6;18(12):e1003868. doi: 10.1371/journal.pmed.1003868. eCollection 2021 Dec.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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HVTN 405/HPTN 1901
Identifier Type: -
Identifier Source: org_study_id
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